Device Classification Name |
Urinary Homocystine (Nonquantitative) Test System
|
510(k) Number |
K112790 |
Device Name |
AXIS-SHIELD 3-REAGENT HOMOCYSTEINE ASSAY FOR SYNCHRON |
Applicant |
AXIS-SHIELD DIAGNOSTICS, LTD. |
THE TECHNOLOGY PARK |
LUNA PLACE |
DUNDEE,,
GB
DD2 1XA
|
|
Applicant Contact |
KAREN HILL |
Correspondent |
AXIS-SHIELD DIAGNOSTICS, LTD. |
THE TECHNOLOGY PARK |
LUNA PLACE |
DUNDEE,,
GB
DD2 1XA
|
|
Correspondent Contact |
KAREN HILL |
Regulation Number | 862.1377
|
Classification Product Code |
|
Date Received | 09/26/2011 |
Decision Date | 05/07/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|